Pharmacometrics, Associate Scientific Director - EMD : Job Details

Pay Competitive

Location Billerica/Massachusetts

Employment type Full-Time

• Req#: 264748

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

Associate Scientific Director, Pharmacometrics (PMX) position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization will be scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

This position will participate in the Quantitative Pharmacology activities to strengthen the PMX platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across disease areas, in alignment with the overall clinical development plan, aligning with the stakeholders, and executing the program strategy/plan to ensure timely deliverable.

This position will be responsible for PMX assignments either executed internally under proper supervision or in collaboration with external PMX CROs by providing close scientific and technical supervision. The incumbent will be expected to manage multiple projects simultaneously and participate in discussions and presentations under proper supervision.

KEY ACCOUNTABILITIES

• Prepare, execute, present, report and/or supervise modeling & simulation projects, summarize and report M&S projects in relevant regulatory submission documents (e.g. CTD 2.7.2)
• Develop and execute MIDD strategies/plans which are fully integrated with the overall clinical development plans
• Apply MIDD methodologies to contribute to decision making at critical milestones based on quantitative principles in close collaboration with partner functions (e.g. clinical pharmacology, biostatistics, data sciences, clinical development, research)
• Strengthen and build internal PMX platform capabilities (e.g. disease progression modeling, clinical trial simulations, model based meta-analysis); Promote innovation by independent research, collaboration within the company or with external partners
• Keep up-to-date with scientific advancement in PMX and share expertise with colleagues
• Represent PMX with internal and external stakeholders

Who You Are:

Minimum Qualifications:

• At least 5 years (Bio)pharmaceutical industry and/or postdoctoral experiences with hands-on pharmacometrics modeling
• Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of pharmacometrics, pharmaceutics, clinical pharmacology, statistics, engineering or mathematics
• Fluency in English

Preferred Qualifications:

• Excellent knowledge and hands-on expertise in R and/or SAS, NONMEM and/ or MONOLIX, SimCYP and related pharmacometrics software
• Promote MIDD internally and externally
• Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
• Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks
• General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus
• Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment
• Strong presentation, communication and organization skills. Ability to communicate technical results to stakeholders.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit our website.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.